Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

K-Number: K182690 · 2018-12-21

ApplicantGenmark Diagnostics, Incorporated
Decision Date2018-12-21
Product CodePEO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182690. The device is classified under product code PEO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K182690.

When did ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel receive FDA 510(k) clearance?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182690.

Who is the listed applicant for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

The FDA product code for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is PEO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01904188Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?RECRUITING

Other records listing Genmark Diagnostics, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelK163652ePlex InstrumentK163636ePlex Respiratory Pathogen PanelK152612eSensor Warfarin Sensitivity Saliva Test

View all 7 devices →

Related Devices (Code: PEO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240627LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑